BE Test Comparator Products

In order to update the "List of Equivalence Test Comparator Drugs and Generic Drugs that Meet Bioequivalence Criteria" which was published in 2020 and to support ease of application of Equivalence Test regulations for business actors, 3 (three) lists have been prepared as follows:

LIST OF EQUIVALENCE TEST COMPARATOR DRUG REGISTERED IN INDONESIA

No ZAT AKTIF BENTUK SEDIAAN KEKUATAN NAMA DAGANG NIE PRODUSEN PENDAFTAR STATUS
91 Deferasirox Tablet Dispersible 500 mg Exjade DKI0667505281A1 Tanggal Terbit 25-11-2020 NOVARTIS PHARMA AG - SWITZERLAND NOVARTIS INDONESIA - INDONESIA Obat Komparator
92 Deferasirox Tablet Salut Selaput 360 Exjade DKI1867509517C1 Tanggal Terbit 02-09-2019 NOVARTIS PHARMA AG - SWITZERLAND NOVARTIS INDONESIA - INDONESIA Obat Komparator
93 Deferasirox Tablet Dispersible 250 mg Exjade DKI0667505281B1 Tanggal Terbit 25-11-2020 NOVARTIS PHARMA AG - SWITZERLAND NOVARTIS INDONESIA - INDONESIA Obat Komparator
94 Deferasirox Tablet Dispersible 125 mg Exjade DKI0667505281C1 Tanggal Terbit 25-11-2020 NOVARTIS PHARMA AG - SWITZERLAND NOVARTIS INDONESIA - INDONESIA Obat Komparator
95 Deferasirox Tablet Salut Selaput 90 Exjade DKI1867509517A1 Tanggal Terbit 02-09-2019 NOVARTIS PHARMA AG - SWITZERLAND NOVARTIS INDONESIA - INDONESIA Obat Komparator
96 Deferasirox Tablet Salut Selaput 180 Exjade DKI1867509517B1 Tanggal Terbit 02-09-2019 NOVARTIS PHARMA STEIN A.G., STEIN - SWISS NOVARTIS INDONESIA - INDONESIA Obat Komparator
97 Deferiprone Tablet Salut Selaput 500 mg Ferriprox DKI1119200117A1 Tanggal Terbit 09-05-2022 APOTEX INC., CANADA SYDNA FARMA - INDONESIA Obat Komparator
98 Desloratadine/ Pseudoephedrine sulfate Tablet Lepas Lambat 120 mg/2,5 mg Aerius D-12 DKI0987101714A1 Tanggal terbit 05-08-2021 PATHEON INC., WHITBY, CANADA, DIKEMAS DAN DIRILIS OLEH SCHERING-PLOUGH LABO NV, HEIST-OP-DEN-BERG, 2220, BELGIUM ORGANON PHARMA INDONESIA TBK - Indonesia Obat Komparator
99 Dexketoprofen Tablet 25 mg Ketesse DKL0405036517A2 Tanggal Terbit 29-03-2018 DEXA MEDICA - INDONESIA DENGAN LISENSI DARI MENARINI INTERNATIONAL OPERATION, GERMANY DEXA MEDICA - INDONESIA Obat Komparator
100 Diacerein Kapsul 50 mg Artrodar DKI0411100101A1 Tanggal Terbit 27-01-2021 TRB CHEMEDICA INTERNATIONAL SA, SWISS TRB PHARMA S.A. - Argentina Pemberi Lisensi TRB CHEMEDICA INTERNATIONAL SA - Switzerland COMBIPHAR - INDONESIA Obat Komparator

EQUIVALENCE TEST COMPARATOR DRUG LIST BASED ON SEARCH IN OTHER COUNTRIES

No ZAT AKTIF BENTUK SEDIAAN KEKUATAN NAMA DAGANG NIE PRODUSEN PENDAFTAR STATUS
31 Efavirenz Tablet 600 mg Stocrin/ Sustiva Malaysia, Australia, USA - Merck Sharp & Dohme (Australia) Bristol Myers Squibb (USA) -
32 Efavirenz Kapsul 50 mg; 200 mg Sustiva USA - Bristol Myers Squibb -
33 Efavirenz (kombinasi dengan Emtricitabine dan Tenofovir) Tablet 600 mg/200mg/ 300 mg Atripla Australia, USA - Gilead Sciences -
34 Efavirenz (kombinasi dengan Lamivudine dan Tenofovir) Tablet 600 mg/300 mg/300 mg Symfi USA - Mylan Laboratories Ltd -
35 Efavirenz (kombinasi dengan Lamivudine dan Tenofovir) Tablet 400 mg/300 mg/300 mg Symfi Lo USA - Mylan Pharmaceuticals Inc -
36 Emtricitabine (kombinasi Tenofovir) Tablet 200/300 mg Truvada Australia, USA - Gilead Sciences -
37 Enalapril Tablet 2,5 mg; 5 mg; 10 mg Vasotec USA - BAUSCH HEALTH US LLC -
38 Entecavir Tablet Salut Selaput 0,5 mg; 1 mg Baraclude Singapore, USA, Philippines AstraZeneca Pharmaceuticals UNITED STATES, USA Bristol Myers Squibb -
39 Ethambutol Tablet 400 mg Myambutol Germany, Switzerland, USA, UK - Riemser Arzneimittel or Teopharma; Labatec Pharma, Switzerland; STI Pharma LLC, USA; Genus Pharmaceuticals Ltd, UK -
40 Felodipine Tablet pelepasan lambat 1,5 mg; 5 mg; 10 mg Plendil Malaysia, Philippines Aztrazeneca Pharmaceutical Co. Ltd, China Astrazeneca -

LIST OF GENERIC DRUGS THAT HAVE MEET THE BIOECIVALENCE CRITERIA IN 2022

No ZAT AKTIF BENTUK SEDIAAN KEKUATAN NAMA DAGANG NIE PRODUSEN PENDAFTAR STATUS
61 Atorvastatin Calcium Trihydrate Tablet Salut Selaput 40 mg Atorvastatin Calcium GKL1433532017B1 Tanggal Terbit 23-03-2021 ETERCON PHARMA - INDONESIA NOVELL PHARMACEUTICAL LAB - INDONESIA Obat Generik
62 Atorvastatin Calcium Trihydrate Tablet Salut Selaput 10.9 mg Truvaz DKL1411643317A1 Tanggal Terbit 25-12-2019 KALBE FARMA - INDONESIA KALBE FARMA - INDONESIA Obat Generik
63 Atorvastatin Calcium Trihydrate Tablet Salut Selaput 20 mg Cholestor DKL1634604317B1 Tanggal Terbit 11-10-2021 DEXA MEDICA - INDONESIA FERRON PAR PHARMACEUTICALS - INDONESIA Obat Generik
64 Atorvastatin Calcium Trihydrate Tablet Salut Selaput 20 mg Removchol DKL1333530017A1 Tanggal Terbit 23-06-2022 NOVELL PHARMACEUTICAL LAB - INDONESIA NOVELL PHARMACEUTICAL LAB - INDONESIA Obat Generik
65 Atorvastatin Calcium Trihydrate Kaplet Salut Selaput 40 mg Avesco 40 DKL1302505209C1 Tanggal Terbit 02-08-2018 DIPA PHARMALAB INTERSAINS - INDONESIA DIPA PHARMALAB INTERSAINS - INDONESIA Obat Generik
66 Atorvastatin Calcium Trihydrate/ Amlodipine Besilate Tablet Salut Selaput 20 mg/ 5 mg Carduo DKL2032720917A1 Tanggal Terbit 19-09-2020 YARINDO FARMATAMA - INDONESIA YARINDO FARMATAMA - INDONESIA Obat Generik
67 Azithromycin Dihydrate Kaplet Salut Selaput 500 mg Zithrax DKL9604413909A1 Tanggal Terbit 31-12-2018 DANKOS FARMA - INDONESIA DANKOS FARMA - INDONESIA Obat Generik
68 Azithromycin Dihydrate Kaplet Salut Selaput 500 mg Zycin 500 DKL0917624109A1 Tanggal Terbit 23-08-2020 INTERBAT - INDONESIA INTERBAT - INDONESIA Obat Generik
69 Azithromycin Dihydrate Kaplet Salut Selaput 500 mg Zarom 500 DKL1621022509A1 Tanggal Terbit 14-08-2017 PYRIDAM FARMA TBK - Indonesia PYRIDAM FARMA TBK - INDONESIA Obat Generik
70 Azithromycin Dihydrate Sirup Kering 200 mg/5 ml Zibramax DKL1008015438A1 Tanggal Terbit 11-03-2020 GUARDIAN PHARMATAMA - INDONESIA GUARDIAN PHARMATAMA - INDONESIA Obat Generik

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